Design and rationale of the mobile health intervention for rural atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) is a highly morbid condition which requires long-term adherence to oral anticoagulation and may be associated with adverse quality of life and health care utilization. We developed a relational agent-an interactive smartphone-based intervention accessible regardless of digital or health literacy-to assist individuals residing in rural, Western Pennsylvania, with AF with chronic disease self-management. METHODS: The "Mobile health intervention for rural atrial fibrillation" is a single center, parallel-arm randomized clinical trial for adults with AF funded by the National Institute of Health's National Heart, Lung, and Blood Institute to enroll 264 participants. All participants receive a smartphone with data plan: The intervention is a 4 month relational agent coupled with the AliveCor Kardia for heart rate and rhythm monitoring provided by smartphone, and the control a pre-installed, smartphone-based application for health-related information (WebMD). The study uses remote recruitment and engagement to enroll individuals who would otherwise be unlikely to participate in clinical research due to rurality. The primary outcome of the trial is adherence to oral anticoagulation, determined by proportion of days covered, as measured at 12 months. The secondary outcomes are quality of life, both AF-specific and general, and health care utilization. The study entails a baseline visit, a 4 month intervention phase, and 8 and 12 month follow-up visits. CONCLUSIONS: This mobile health trial tests the effectiveness of a smartphone-based relational agent to improve clinical and patient-reported outcomes in rural-dwelling individuals.

Rurality and atrial fibrillation: a pathway to virtual engagement and clinical trial recruitment in response to COVID-19.

Study Objective: To summarize trial adaptation from in-clinic to virtual design in response to the SARS-2 coronavirus-2 (COVID-19). Design: A clinical trial of a mobile health intervention to improve chronic disease self-management for rural individuals with atrial fibrillation (AF). The trial has a 4-month intervention - accessible regardless of health or digital literacy - to enhance AF medication adherence and patient experience with 8- and 12-month assessments of sustainability. Setting: Rural, western Pennsylvania. Participants: Rural individuals with AF receiving oral anticoagulation for stroke prevention. Interventions: Enrolled participants underwent a telephone-based orientation, provided verbal consent, and were randomized using a digital platform. They received a smartphone with intervention or control applications and a curriculum on usage tailored for study arm. Participants received study assessments by mail with telephone-based administration and contact for the 12-month trial. Main Outcome Measures: Successful adaptation to virtual engagement and recruitment. Results: The study enrolled 18 participants during in-clinic recruitment (January-March 2020). From 5/1/2020 to 5/6/2021 the study team enrolled 130 individuals (median age 72.4 years, range 40.8-92.2; 49.2% women, 63.1% without college degree, and 45.4% with limited health literacy. Retention of participants enrolled using virtual methods during the 4-month intervention phase is 92%. Conclusions: We report a virtual trial of a mobile health intervention for rural individuals with AF. Our successful implementation suggests promise for engaging geographically isolated rural individuals, potential to enhance digital health access, and advance rural health equity.